BioAtla(BCAB)

Search documents
BioAtla Announces Regulatory Update on Clinical Development Plan for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA
Globenewswire· 2025-09-08 12:00
FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approvalCompany continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner early next yearCompany maintains previous guidance for completion of a strategic partnership with one of our advanced clinical assets this year SAN DIEGO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global ...
BioAtla(BCAB) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $13.7 million for Q2 2025 from $16.2 million in Q2 2024, a reduction of $2.5 million primarily due to workforce reduction and program prioritization [11][12] - General and administrative (G&A) expenses were $5 million for Q2 2025, down from $5.8 million in Q2 2024, reflecting lower stock-based compensation and headcount-related expenses [12] - Net loss for Q2 2025 was $18.7 million compared to a net loss of $21.1 million in Q2 2024, indicating improved financial performance [12] - Cash and cash equivalents as of June 30, 2025, were $18.2 million, down from $49 million as of December 31, 2024, highlighting a significant cash burn [13] Business Line Data and Key Metrics Changes - The dual conditionally binding EpCAM CD3 T cell engager BA-3182 is showing promising results in its Phase 1 dose escalation study, with evidence of objective tumor reductions in patients with various solid tumors [5][6] - The CABWAR2 ADC OSV demonstrated an overall response rate (ORR) of 45% in patients with metastatic HPV-positive head and neck cancer, significantly outperforming the standard of care [8] - The McVe ADC has shown exceptional overall survival rates among heavily pretreated patients with MKRAS non-small cell lung cancer, with one-year and two-year landmark survival rates of 67% and 59%, respectively [9] Market Data and Key Metrics Changes - The company is focusing on indications with high unmet needs, such as colorectal cancer and cholangiocarcinoma, which have shown high expression of EpCAM and limited available therapies [18][19] - The company is progressing with partnering discussions across its CAB portfolio, indicating a strategic focus on collaboration for development and commercialization [10] Company Strategy and Development Direction - The company plans to present its strategy to NASDAQ to regain compliance with listing requirements, indicating a proactive approach to maintain its market position [10] - The company is positioning its OSV asset for a planned Phase III study and is seeking FDA guidance, reflecting a commitment to advancing its clinical pipeline [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in closing one or more partnering transactions this year, which could enhance financial stability and support key clinical activities [14][25] - The company is managing cash resources carefully and expects quarterly cash burn to decrease as it completes Phase II clinical trials [13][14] Other Important Information - The company has completed due diligence for one of its assets and is at the term sheet stage for a potential partnership, indicating progress in its strategic initiatives [10][11] Q&A Session Summary Question: Regarding the expansion cohort study, which indication is being pursued? - Management indicated that colorectal cancer is particularly attractive due to high EpCAM expression and unmet needs, although no formal decision has been made yet [18] Question: What are the tumor reduction levels for patients in the colorectal cancer cohort? - Management confirmed three patients with colorectal cancer have shown tumor reductions of -6%, -8%, and -10%, with additional patients in other cohorts also showing reductions [20] Question: Will there be updates on dosing cohorts? - Management stated that updates will be provided later this year, potentially during the ESMO meeting in October [22]
BioAtla(BCAB) - 2025 Q2 - Quarterly Report
2025-08-07 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to BIOATLA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85-1922320 (State or other jurisdiction of incorporation or organization) 11085 ...
BioAtla(BCAB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 20:30
Conditionally Active Biologics: Transforming Cancer Therapy Corporate Presentation August 2025 BioAtla | Overview 2 These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Presentation and are subject to risks and uncertainties, including those described in the Company's filings with the SEC, including but not limited to the Company's latest Annual Report on Form 10-K and any subsequently filed Qu ...
BioAtla(BCAB) - 2025 Q2 - Quarterly Results
2025-08-07 20:06
SAN DIEGO, August 7, 2025 – BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics using its proprietary CAB platform for the treatment of solid tumors, today announced its financial results for the second quarter ended June 30, 2025 and provided highlights on its clinical programs. "We continue to be encouraged by the performance of our dual CAB EpCAM x CD3 bispecific TCE, BA3182, in Phase 1 and rem ...
BioAtla to Announce Second Quarter 2025 Financial Results and Provide Business Highlights on August 7, 2025
GlobeNewswire News Room· 2025-08-04 12:00
SAN DIEGO, Aug. 04, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that it plans to host a conference call and webcast on Thursday, August 7, 2025 at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2025 and provide business highlights. Conference Call and Webcast Information Date: T ...
BioAtla Announces Upcoming Oral Presentation at the 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting
Globenewswire· 2025-07-17 12:00
Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] - The company will present a first-in-human phase I study of a dual-CAB EpCAM x CD3 bispecific T-cell engager (TCE), BA3182, targeting treatment refractory metastatic adenocarcinoma at the 2025 ESMO TAT Asia Meeting [2] Company Overview - BioAtla operates in San Diego, California, and has a presence in Beijing, China through a partnership with BioDuro-Sundia for preclinical development services [3] - The company utilizes its proprietary CAB platform technology to develop novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3] - BioAtla holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3]
BioAtla Presents Phase 2 Ozuriftamab Vedotin (Oz-V) Clinical Trial Data Demonstrating Compelling Antitumor Activity in HPV-Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) at the 1.8 mg/kg Q2W dosing regimen
GlobeNewswire News Room· 2025-06-02 12:00
Core Insights - BioAtla, Inc. announced promising Phase 2 trial results for Ozuriftamab Vedotin (Oz-V) in HPV+ OPSCC patients, showing a 45% overall response rate (ORR) and a 100% disease control rate (DCR) [1][4] - The trial highlights a significant unmet need in the second-line and beyond HPV+ OPSCC patient population, where standard treatments have reported an ORR of only 3.4% [1][4] - The company plans to finalize the Phase 3 trial design for Oz-V with the FDA [1] Group 1: Clinical Trial Details - In the Phase 2 clinical trial, 40 heavily pretreated SCCHN patients received Oz-V at a dosage of 1.8 mg/kg, administered either every two weeks or on specific days of a 21-day cycle [2][7] - Tumor assessments were conducted via CT or MRI every 6 weeks for the first 12 weeks, then every 8 weeks up to one year [2] - Among the 40 patients, 22 had HPV+ OPSCC, with a median of 3 prior lines of therapy and a high failure rate of previous anti–PD-1 and platinum therapies [7] Group 2: Efficacy and Safety Data - In HPV+ OPSCC patients, Oz-V demonstrated an ORR of 45% (5 out of 11 patients) and a DCR of 100% (11 out of 11 patients) [7] - The median duration of response was 9.9 months, with median progression-free survival at 4.7 months and median overall survival at 11.6 months [7] - Most adverse events were low grade, with fatigue (57%) and anemia (32%) being the most common; only 15% experienced grade ≥3 adverse events [7] Group 3: Regulatory and Market Potential - The company believes there is potential for accelerated approval and full approval of Oz-V in the HPV+ OPSCC market [4] - Oz-V has received Fast Track Designation from the FDA to facilitate discussions regarding the proposed Phase 3 study [7][8] - The drug targets ROR2, a receptor associated with poor prognosis and resistance to therapies, indicating a strategic focus on addressing significant market needs in solid tumors [8]
Bioatla (BCAB) 2025 Conference Transcript
2025-05-07 15:00
Summary of BioAtla (BCAB) Conference Call Company Overview - BioAtla is a clinical stage oncology company based in San Diego, California with four clinical assets, three of which are in phase two [4][5] - The company utilizes a conditionally active biologic platform that enhances the therapeutic index of its therapies, increasing both potency and safety [4][5] Key Points on Clinical Assets - The platform allows for immediate binding to tumor targets without requiring an activation step, which enhances the therapeutic window [7][8] - BioAtla is engaged in multiple discussions to advance its molecules into phase three trials with partners [5] Axle Program - The Axle program targets MKRAS mutations in lung cancer, with a reported overall survival rate of 59% over two years, significantly higher than previous treatments [11][34] - Historical data shows that previous treatments for MKRAS non-small cell lung cancer had one and two-year survival rates of less than 40% and 20%, respectively [34] - The company is in discussions to randomize against docetaxel in preparation for a phase three trial [38] EpCAM Program - The EpCAM program is in a phase one dose escalation study, targeting various adenocarcinomas, including non-small cell lung cancer and colorectal cancer [14][30] - The dual cab technology allows for enhanced selectivity, with a potential market opportunity estimated in the multi-billion dollar range [30][31] - Initial data shows patients with colorectal cancer experiencing over a year without progression [15] Market Potential - The EpCAM target is expressed in 100% of colon cancer tumors, presenting a unique opportunity in the oncology market [31] - The potential for a pan-cancer drug across adenocarcinomas is highlighted, with significant market implications if successful [30] Future Steps and Partnerships - BioAtla is focused on advancing its clinical programs, particularly the EpCAM and Axle assets, with plans for potential partnerships to enhance development and funding [41][50] - The company has a cash position of $32 million, sufficient to carry operations into 2026, while actively seeking non-dilutive financing through partnerships [57][59] Conclusion - BioAtla is positioned in a promising space within oncology, with innovative technologies and strong survival data supporting its clinical programs. The company is optimistic about future partnerships and the potential for significant market impact with its therapies [52][56]
BioAtla(BCAB) - 2025 Q1 - Earnings Call Transcript
2025-05-06 21:32
Bioatla (BCAB) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Bruce Mackle - Managing DirectorJay Short - Co-Founder, CEO & ChairmanRichard Waldron - Chief Financial OfficerEric Sievers - Chief Medical OfficerReni Benjamin - Managing DirectorYu He (Arthur) - Equity Research Vice President Conference Call Participants Jeet Mukherjee - Vice President & Biotechnology Analyst Operator Good day, everyone, and welcome to today's BioAtlas First Quarter twenty twenty five Earnings Call. At this ...